Low Back Pain
Conditions
Keywords
Intervertebral disc degeneration, Bone Disease, Musculoskeletal disease, Spinal disease
Brief summary
The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.
Detailed description
The primary objective of this post-market study is to collect data to asses the long term outcome of the InterFuse T (tm) device in \[patients undergoing interbody fusion. The primary endpoints of the investigation will include assessment of the maintenance of disc height and fusion rates demonstrated by radiographic evidence based on plain radiographs. Fusion is defined as a bone bridging across the disc space at the level of the InterFuse T implant. Length of stay, implant migration, implant subsidence, re-operation rate and opioid use will be recorded. It is anticipated that outcomes with the InterFuse T Interbody Fusion Device will be comparable to or better than the historical published results for other non-modular TLIF devices and to the control device used concurrently in the study
Interventions
DEVICEInterFuse T
Transforaminal Lumbar Interbody fusion (TLIF)
DEVICEStandard of Care TLIF (Stryker AVS Unilif)
Transforaminal Lumbar Interbody Fusion (TLIF)
Sponsors
Vertebral Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* meets indications for an interbody fusion (determined by the study investigator) * Has documented conservative (non-operative ) treatment for at least 3 months * Has a VAS back pain of \> or = 60mm * Has an ODI \> or = 40% * at least 18 years of age and skeletally mature * Willing and able to comply with study requirements * Patient's condition is appropriate for surgery * Agreed to participate in study
Exclusion criteria
* Has severe osteoporosis or osteopenia * Grade 3 or higher Spondylolisthesis * Diffuse multilevel neoplastic disease such that no adjacent normal segment exists for engagement or instrumentation * Body Mass Index (BMI) \> 40 * Patient has active infection * Patient is pregnant or planning to become pregnant * Patient is mentally ill or has history of drug abuse * Patient has known allergy to Polyetheretherketone (PEEK), stainless steel or Tantalum * Patient is currently enrolled in an investigational spine study * Has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease * patient bhas symptomatic fibrous arachnoiditis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fusion rates | 12 months | Assessment of the fusion rates as demonstrated by radiographic evidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | up to 12 months | Visual Analog Scale pre-op compared to VAS score at 2-4 weeks, 6 months and at 1 year |
| Oswestry Disability Score (ODI) | 12 months | Oswestry Low Back Pain Disability Questionaire |
| SF-36 | 12 months | Rand 36-item Health Survey (version 1.0) |
| Maintenance of disk height | 12 months | comparison of disk height pre-op versus at 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | up to 2-4 weeks | — |
| Opioid use | baseline, at 2-4 weeks, at 6 months and at 12 months | usage of pain medication |
Countries
United States
Contacts
Primary ContactJeff Felt, MD
Backup ContactBen A. Wasscher, MBA
Outcome results
None listed